Pneumonia, Ventilator-Associated, Respiratory Failure, Wounds and Injuries
Conditions
Keywords
Chlorhexidine, Randomized Controlled Trial, Emergency Medical Services, Intubation, Endotracheal
Brief summary
Traumatic injury in rural America is a significant cause of morbidity and mortality, and the challenges of a rural trauma system can put patients at unique risk. Prolonged transport times to a trauma center, stopping for care at referring hospitals, and longer exposure to care-associated factors distinguish rural patients from their urban counterparts. Ventilator-associated pneumonia (VAP) is a significant risk in rural patients, increasing hospital stay, healthcare costs, and even mortality in the critically injured. The investigators propose a pilot study to test the hypothesis that a single dose of oral chlorhexidine gluconate (antiseptic) for trauma patients in the prehospital environment will decrease subsequent development of early VAP. Chlorhexidine is currently a standard therapy in intensive care units to prevent airway colonization and subsequent development of VAP. Demonstrating safety and effectiveness of prehospital infection control practices could significantly improve outcomes of traumatic injury in rural America.
Interventions
DRUGChlorhexidine gluconate
Study solution will be applied to the oropharynx and will be distributed for 15 seconds with a swab stick. No suction will be applied for at least 30 seconds.
Sponsors
Nicholas M Mohr
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Adults (age \>= 18 years) * Endotracheal intubation * Transported by air ambulance * Traumatic injury * Interfacility transport (no flights from scene) en route to University of Iowa Hospitals and Clinics)
Exclusion criteria
* Known or suspected pregnancy * Prisoners * Patients diagnosed with pneumonia prior to transfer * Known allergy to chlorhexidine gluconate * Surgical airway (tracheostomy or cricothyroidotomy) * Massive aspiration * Anticipated nonsurvivable injury (survival projected \< 24 hours)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Clinical Pulmonary Infection Score (CPIS) | 48-72 hours |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Pneumonia - CDC | 5 days | This is the diagnosis of pneumonia using CDC criteria within 5 days of admission. |
| Pneumonia - Treated | 5 days | This is the diagnosis of pneumonia defined as antibiotic treatment of suspected pneumonia by the treating clinician. |
| Pneumonia - Research | 5 days | This is the diagnosis of pneumonia within 5 days as adjudicated by 3 clinicians blinded to treatment allocation. |
| 28-day ventilator-free days | 28 days | — |
| Pneumonia - CPIS | 5 days | This is the diagnosis of pneumonia within the first 5 days defined by CPIS score \>=6. |
| Hospital Mortality | 28-days | — |
| Tracheostomy Rate | 28 days | — |
| Tracheal colonization | 48-72 hours | This analysis will be completed in two ways: the raw analysis will use a chi-squared test to test the null hypothesis that the distribution of semi-quantitative tracheal colonization is the same in the two groups. A second analysis will be performed using the ordinal shift method to compare the change (shift) in the semiquantitative score between admission and 48-72 hours. |
| 28-day ICU-free days | 28 days | — |
Countries
United States
Outcome results
None listed